Intellirod Spine develops and manufactures wireless sensors for wearable, intraoperative, and implantable medical device applications. Product designs include Wi-Fi, RFID, Bluetooth communication, force and proximity sensing, and cloud connectivity for IoT products. Responsible for leading design, development, and operations of multi-discipline product development teams. • Managed surgical clinical trials and FDA filing, leading to De Novo approval (DEN180012)• Developed and conducted training for surgeons, provided guidance during surgical procedures, and conducted post-surgical assessments • Responsible for verification and validation activities to meet FCC and FDA regulatory requirements• Managed electronic, firmware, and hardware development for Class I and Class II medical devices • Managed the development, qualification, and implementation of manufacturing, welding, surface mount technology (SMT), and ETO sterilization processes.• Responsible for developing product roadmaps, development schedules, and program cost models • Completed cost reduction projects reducing manufacturing costs by 23% and material costs by 26%• Revised Quality Management System policies and conducted implementation training to improve processes for risk mitigation, design controls, and supplier management processes• Managed the CAPA process and implemented the use of investigational tools (i.e. 5-Why, Ishikawa)• Conducted supplier qualification audits and managed supplier performance improvement projects• Established measurement and reporting process for NPD, CAPA, and cost improvement KPI’s

Invacare, with $1.2 billion in annual sales, is the global leader of innovative home and long-term care medical products. Responsible for an international team of 26, including managers, designers, engineers, and project leaders. Ensured efficient design, manufacturing, and post market support to maintain the quality and profitability of products in an ISO 9001, ISO 13485 environment. Reporting to the VP of Research and Innovation.• Managed remediation activities in the areas of CAPA, design controls, process controls and post-market surveillance, as part of the successful resolution of FDA injunction• Led supplier improvement activities, PPAP advancement initiative, and 5S program• Developed metrics to track engineering performance to meet objectives for quality and profitability• Managed engineering budgets for equipment, training, and external engineering resources• Improved design and release to manufacturing processes, improving implementation time by 30%• Reduced the quantity of active design changes by 35% via improvements to design control processes• Led a cross-functional project team improving manufacturing processes to reduce respiratory product failures, leading to reduced warranty costs of $500k in the first year• Developed a Rapid Response Team (RRT) program to provide fast and flexible solutions for business-critical projects with focus on safety, quality, compliance, and sales revenue• Implemented a dealer service program to reduce service and warranty costs by $1.3 million per year

Lumitex designs and manufactures custom LED backlighting and controls for medical, consumer, and automotive applications. Managed new product development for fiber-optic applications. • Implemented a New Product Development (NPD) stage gate process for lighting products• Provided competitive product SWOT analysis, including cost and performance comparisons• Supported audits for automotive and FDA• Led changes for manufacturing equipment configurations and process improvements to achieve production efficiency gains of 25%• Manage budgets for new equipment, employee training, and external engineering resources• Managed root cause analysis and implement corrective action programs (CAPA)• Supported audits for automotive and FDA• Led continuous improvement programs reducing costs by 15% and improving reliability by 12%,

TTI Floorcare North America was founded in 2007 and is the home of the Hoover and Dirt Devil brands. Responsible for leading the design and implementation of electrical systems for floor- care and cordless products. Managed a design team of six engineers and technician for the development of PMDC, Series Universal, Brushless DC motors, and electrical controls. • Successfully completed a motor redesign program that improved product performance and reliability, while reducing costs by $2.5 million per year • Developed procedures and documentation for qualification testing of consumer products to appropriate UL, ASTM, and Energy Star standards• Managed Asian suppliers for design, testing, and manufacturing of motors and fan systems• Managed sustaining engineering projects which targeted quality improvements, identifying alternate components and suppliers, and cost reduction initiatives• Lead the activities of cross-functional teams to achieve financial, performance, and delivery related goals for new product development and product improvement projects

Dynamic Controls is the world’s leading manufacturer of controls for powered medical devices, including power wheelchairs, mobility scooters, and respiratory products. Responsible for developing technical specifications, managing new product implementation, and providing engineering support for a worldwide customer base. • Managed nine individual product launches for power wheelchair and scooter applications • Benchmark competitive products to build product landscapes and SWOT analysis • Developed a 3-year strategy for new product development of power electronic control systems• Conducted verification testing for user programming and configuration software programs

CMC is a provider of industrial control and automation solutions such as Engineered Systems, Motion Controllers, Web Tension Control, Tension Transducers and Load Cells. Responsible for developing motion control solutions for an OEM customer base. These AC and DC systems provided control solutions for paper converting, processing, and food packaging applications.• Responsible for specifying system requirements for AC and DC controls systems • Managed projects for motion control retrofit solutions in the steel and paper processing equipment markets• Created quotation database for tracking customer and product activity• Developed and conducted sales and technical training seminars• Wrote technical product specifications for motion control systems• Completed on-site service engineering and system commissioning